Trauma as a Trigger for Autoimmunity

University Hospital, Basel, Switzerland50 enrolled

Overview

To analyse the immunological reaction to Trauma (pertrochanteric femoral fracture with consequent osteosynthesis) in the first weeks up to one year postoperatively with focus on the development of autoimmunity.

This project represents a unique study of the influence of trauma on the immune system. It addresses the question whether an excess of apoptotic/necrotic cells can induce an at least transient autoimmune phenomena in humans. If the hypothesis of a transient induction of autoimmunity by trauma proves to be correct, this study will provide a novel insight into the pathogenesis of autoimmune diseases.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Autoimmunity

Interventions

Comparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line.DIAGNOSTIC_TEST

To analyse whether patients with pertrochanteric femoral fracture with consecutive gamma-nailing develop any laboratory signs of transient autoimmunity (comparison of the levels of ANA; in order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * pertrochanteric femoral fracture (≤7 days) * planned gamma nail osteosynthesis * ability to give written informed consent Exclusion Criteria: * Severe hepatic and renal failure * current active oncological disease * current immunosuppressive or biological therapy * known systemic autoimmune disease * foreseeable lack of complete follow-up (e.g. due to generally poor health) * cognitive impairment (delirium, dementia, alteration of consciousness) * insufficient knowledge of project language * pregnancy

Locations (1)

University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Change in ANA

Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy = indirect immunofluorescence on a Hep-2 cell line). In order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used (NOVA View, INOVA Diagnostics

Time frame: Preoperative (1-2 days preoperative) and 12 weeks postoperative

Secondary Outcomes

Change in ANA

Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy)

Time frame: 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative

Change in Antibody level against double stranded deoxyribonucleic acid (Anti-dsDNA)

serum level of Anti-dsDNA (U/ml)

Time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative

Change in Antibody level against Anti-Cardiolipin

serum level of Anti-Cardiolipin (U/ml)

Time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative

Change in Antibody level against complement component C1q (Anti-C1q)

serum level of C1q (U/ml)

Time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative

Change in Antibody level against Sjögren's-syndrome-related antigen A (Anti-SSA/Ro)

serum level of Anti-SSA/Ro (U/ml)

Time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.